Speakers name: Dr Beatriz Vaquerizo
I have the following potential conflicts of interest to report:
Research contracts Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s)
I do not have any potential conflict of interest
Potential conflicts of interest
Percutaneous Coronary Intervention With a New Placlitaxel Eluting Balloon for the
Treatment of in-Stent Restenosis and Small Vessel Disease: Mid-term Outcomes of the
Spanish Multicenter Registry
B. Vaquerizo1, A. Serra1, F. Miranda1, V. Martnez2, JA. Gmez-Hospital2, A. Cequier2, A. Iiguez3, JA. Baz3, G. Bastos3, E. Fernndez4, O.
Rodrguez4, J. Mauri4, M. Sdaba5, JA. Rumoroso5, A. Subinas5, R. Garca-Borbolla6, A. Gomez6, J. Oneto Otero6, A. Martnez7, F. Bossa8, S.
Rodrguez8, R. Moreno9, A. Saez9.
H. Del Mar1 (Barcelona), H. de Bellvitge2 (Barcelona), H. Meixoeiro3 (Vigo), H. Tras i Pujol4 (Barcelona), H. de Galdakao5 (Galdakao), H. de Jerez6 (Jerez), H.
Gral. de Castelln7 (Castelln), H. Univ. Canarias8 (Tenerife), H. La Paz9 (Madrid)
In everyday practice, there is a small but significant population in whom the use of either BMS or DES may be considered inappropiate or even harmful
AHA Congress 2009.Orlando Spanish Dior Registry
In- stent restenosis De novo lesions in small vessels ( 2.5mm) Bifurcated lesions (111, 101, 011) Bifurcated lesions (001 of Medina classification) Contraindication to dual antiplatelet therapy
Background
The Spanish Dior Registry is a real world, prospective and multicenter registry of
percutaneous coronary intervention set up to assess the efficacy and safety of a new
placlitaxel--eluting balloon (DiorMT, Eurocor/Palex) in these settings
AHA Congress 2009.Orlando Spanish Dior Registry
Objectives
In order to overcome the potential limitations of the stents.
191 patients and 199 lesions treated by using this new placlitaxel-eluting balloon (3g/m2 balloon surface area) were included in this registry
Prospective real-world multicenter registry : 9 Spanish centers Dual antiplatelet therapy (DAT) for at least 3 months Clinical FU planned at 1, 6 and 12 months Angiographic follow-up at 6-8 months in 40% of patients (3 centers)
Exclusion criteria: Clinical: STEMI
Clinical/Angiographic eligible patient
Target lesion Pre-dilatation (Shorter balloon than the Dior)
Dior dilatation: above nominal pressure + at least during 60sec
No angio success: BMS Follow-up
Clinical FU at 1 and 6 months and 1 year after the index procedure Angiographic FU at 72 months in 3 centers (40% of population)
www.registrodior.com
Angiographic success: a final residual lesion stenosis > 50% in the TL and absence of > type B coronary dissection
Studys Flowchart
1st and 2nd Generation Paclitaxel- Eluting DIOR-Balloon (Eurocor-Palex. CE Marked. )
1.Paclitaxel
2. Balloon designed with 3 folds of micro-porous surface. The three-folded balloon protects the loaded drug from the early
wash-off effect
3.-Coating method 3g/mm2 balloon-surface
paclitaxel-coating
DiorTM (EuroCOR, GmbH, Germany)
Micro-crystals (following dimethilsulfate treatment)
Dior 1st G
+
Posa et al. CAD 2008
Dior 2nd G
The drug is dissolved in Shellac FDA approved
substance graded as a food
+
Hemetsberger R, Posa A et al. J. Kardiol 2009
Solubilizing agent to increase optimal drug
delivery
Cell-culture experiments: the brief contact between vascular and smoth-muscle cells and lipophilic taxane compounds (paclitaxel) inhibits the proliferation of such cells
DIOR-Balloon (Eurocor-Palex)
Dior-DEB was significantly more effective in inhibition of neointimal hyperplasia as compared with non-coated balloon.
Randomized N=33 Pre-clinical animal model of PCI:
Hemetsberger R, Posa A et al. J. Kardiol 2009
Porcine coronary artery overstretch injury model
Inflation time-dependent tissue concentrations
Hemetsberger R, Posa A et al. J. Kardiol 2009
Plateau concentration of the drug tissue
293 526
19644 20236
18459
Novel coating technology (Shellac) of DIOR 2G compared with 1st G: Maximum tissue concentration of paclitaxel- inflation time of 30-45sec
(60 sec Dior 1G) (better tolerated) 20-fold higher tissue concentration
Tissue concentration of paclitaxel dependig on balloon inflation time
Hemetsberger R, Posa A et al. J. Kardiol 2009
Homogeneous (vertical and longitudinal) distribution of paclitaxel* on the vessel by simple diffusion, in contrast with DES
Fluorenscence microscopy images
Tissue distribution of the drug on the vessel
Fluorescence images of DIOR showed: (Oregon green 488 Fluorescent paclitaxel conjugate )
PEB Vertical penetration of paclitaxel at 1 and 2 mm deepness dependig on balloon inflation time
Promising initial clinical results in patients with: In-stent restenosis:
Randomized trials: Paccocath ISR I10 y ISR II11 / 108 pts.) Plain balloon vs paclitaxel balloon (matrix coating)
Randomized trial : PEPCAD II trial (IRS of BMS) (66/65): Paclitaxel balloon (SeQuent Please) (matrix coating) vs Paclitaxel stent12
Registry (Dior): Dior (60) vs Cypher(80) vs Taxus(80) (Gyngysi et al. ESC-09)
10. Scheller B et al . New Engl J Med 2006
11. Scheller B et al. Clin Res Cardiol 2008 13. Fanggoday JC et al. Cath Cardiovasc Interv 2008
New concept/modality of PCI: Drug-eluting balloon
Bifurcated lesions DEBIUT registry (Dior; 20 pts, 1-4 mo FU)13 TCT 09: PEPCAD 5 registry: (28 pts, 9 mo, FU) (matrix coating)
11. Unverdorben M, Scheller B et al. Circulation 2009
Exclusion criteria: STEMI and non STEMI (48-72h.)11,12,13 DES in-stent restenosis12, renal failure11,12, FE 30%13 Small vessel 2.5mm12,13
Age (years) (meanSD) 65.610.4 Male gender 80.0 (152) Risc Factors Diabetes 31.6 (60) Hypertension 71.1 (135) Dyslipidemia 63.2 (120) Current Smoker 31.1 (59) Renal impairment (creat >1.3mg/dl) 15.6
(25) Hystory of MI 38.9 (74) PCI 66.8 (127)
Clinical presentation ACS (%) 54.2 (103) STEMI >24h 4.7 (9) LVEF ( 50%) 31.5
(45) 3 vessel disease 21.6 (41)
Demographic and Clinical Characteristics: N=191
Unless specified otherwise, values are % and (n) of patients
Age (years) (meanSD) 65.610.4 Male gender 80.0 (152) Risc Factors Diabetes 31.6 (60) Hypertension 71.1 (135) Dyslipidemia 63.2 (120) Current Smoker 31.1 (59) Renal impairment (creat >1.3mg/dl) 15.6
(25) Hystory of MI 38.9 (74) PCI 66.8 (127)
Clinical presentation ACS (%) 54.2 (103) STEMI >24h 4.7 (9) LVEF ( 50%) 31.5
(45) 3 vessel disease 21.6 (41)
Baseline Lesion Characteristics
Indication for use of DIOR In-stent restenosis (ISR) 56.0 (107) De novo lesion small vessel
Radial approach 54.2 (103) 6F- guide catheter 87.9 (167) Number of stent implanted outside the target lesion 32.6 (62) DES outside the target lesion 24.2 (46) Pre-dilatation (plain balloon) 100 (199) Diameter, mm (meanSD) 2.40.5 Lenght, mm (meanSD) 14.6 3.9 Dior Balloon Diameter, mm (meanSD) 2.70.5 Length, mm (meanSD) 19.25.1 Main balloon presure, mmHg, (meanSD) 13.73.5 Inflation time (sec). (meanSD) 94.9 37.8 Post-dilatation 27.5 (42) IIb-IIIa inhibitor 2.6 (5)
Baseline Procedural Characteristics
Unless specified otherwise, values are % and (n) of patients
0.6%(1/173)
%
Non Hierarchical Ranking
Cumulative Events at 1 month (Completed in 173 patients)
* CPK and/or Troponin > 3 times ULN value + 1 criteria of: chest pain and/or typical changes on ECG
0.6%(1/173) 0.6% (1/173) 0%**
**Definitive segment treated thrombosis (ARC). MACE: MI and/or TLR and/or Cardiac death
0.6%(1/173) 1.2% (2/179) 1.2% (2/173)
91.6% of Angiographic success BMS after dior use 8.4%:>type B dissection (5.2%), recoil >50% (3.2%)
2.9% (3/104)
%
Non Hierarchical Ranking
4.8% (5/104)
2.9% (3/104)
7.7% (8/104)
0%
4.8% (5/104)
7.7% (8/104)
MACE: MI and/or TLR and/or cardiac death
Cumulative Events at 6 month (Completed in 104 patients)
Angiographic restenosis
Variable Pre-PCI Post-PCI 6mo FU
Reference diameter 2.20.4
Lesion lenght 15.77.2
MLD 0.50.3 1.70.4 1.30.6
Diameter stenosis % 78.414.5 23.49.6 39.324.1
Acute Gain 1.20 0.4
In-segment late loss 0.40.6
Binary Restenosis, (n) % 3 (10%)
3 center with systematic angio FU at 6-9 months For this analysis only centers with >60% angio FU were considered 1 center 93.8% (30/32pts) angio FU completed at 6.61.6mo.
Center with 72.5% of small vessel as indication of Dior use
Unless specified otherwise, values are mm (meanSD)
Variable Pre-PCI Post-PCI 6mo FU
Reference diameter 2.20.4
Lesion length 15.77.2
MLD 0.50.3 1.70.4 1.30.6
Diameter stenosis % 78.414.5 23.49.6 39.324.1
Acute Gain 1.20 0.4
In-segment late loss 0.40.6